Nova Biomedical is seeking a Quality Assurance Post Market Manager to lead a team in our Waltham, MA location. Reporting to the Quality& Regulatory Affairs Director, this role will ensure continual improvement to Nova Biomedical’s Compliant Handling system. This role will be responsible for achieving key metrics and compliance to applicable regulations.
Nova Biomedical is a company dedicated to using advanced technology to develop better blood testing analyzers for medical use. Nova is the largest privately owned IVD company in the U.S. with over 1,200 employees globally. Our eight percent compounded annual growth over nearly a decade is more than double the IVD market growth, making Nova one the fastest growing IVD companies in the world.
Oversees the Complaint Reporting database
Makes determinations on product incidents based on Nova Biomedical’s procedures
Assess complaints to determine reporting requirements to regulatory authorities
Ensures complaint investigations are properly analyzed for quality, safety and reliability and are closed in a timely manner.
Notifies and works with Manufacturing, Research and Development and other affected parties to address and resolve detected problems
Manage customer satisfaction response database and trend and report data to management
Ensures appropriate customer communication as required and resolves remaining customer issues
Prepares metrics to ensure post-market goals are achieved
Initiate and facilitate corrective or preventive actions as needed
Escalates issues to management, as deemed necessary
Ensures team maintains current knowledge on worldwide post-market requirements
Ensure proper reporting of adverse events to applicable regulatory agencies
Interact with Regulatory agency officials
Lead team to ensure performance indicators are met
Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.
Must have BS Degree in Sciences or equivalent
8+ years of QA experience in the medical diagnostic, device industries. Experience leading or supervising a Quality Assurance Post Market team.
Complaint handling and MDR experience; FDA 21CFR pts 803, 806 and 820, IVDD, MDSAP, ISO 13485 knowledge
Experience with Complaint Handling, Adverse Event Reporting, Field Actions, and Recalls.
Strong communication and presentation skills
Working knowledge of GMPs is required.
Knowledge of Pivotal CRM software.
About Nova Biomedical
Nova Biomedical develops, manufactures, and sells advanced technology blood testing analyzers. We employ over 1,200 people, with sales and service subsidiaries in eight countries and distributors in more than 91 additional countries. Nova has manufacturing facilities in Waltham and Billerica, Massachusetts; and Taipei, Taiwan. Nova is one of the 25 largest in vitro diagnostic companies in the world and the largest privately owned in vitro diagnostic company in the United States.